118 – What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways.

Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and maintain these files in biopharma companies. Doug provides case examples, discusses trends, future prospects of DMFs and MAFs, and offers advice for companies dealing with aspects of master file content.

Markers:

Timestamps

01:46 Understanding Drug Master Files and Device Master Files
05:11 Doug's Experience with Master Files
07:43 Challenges and Advantages of Using Master Files
11:33 The Role of Device Master Files
12:44 Overlap Between DMFs and MAFs
31:14 The Future of Master Files

Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.